PART 6MANUFACTURE AND IMPORTATION OF INVESTIGATIONAL MEDICINAL PRODUCTS

Exemption for hospitals and health centres37

1

The restriction imposed by regulation 36(1) shall not apply to the assembly of an investigational medicinal product where the conditions specified in paragraph (2) are satisfied.

2

The conditions referred to in paragraph (1) are that—

a

the assembly is carried out in—

i

in a hospital or health centre, and

ii

by a doctor, a pharmacist or a person acting under the supervision of a pharmacist; and

b

the investigational medicinal products are assembled exclusively for use in—

i

that hospital or health centre, or

ii

any other hospital or health centre which is a trial site for the clinical trial in which the product is to be used.